Atomizer in the form of an inhaler for medical aerosol therapy

Abstract

Disclosed are an atomizer (1) for a fluid (2), especially for medical aerosol therapy, and a filter (42) for said atomizer in order to prevent germs from spreading. The atomizer comprises a protective device (32) for preventing germs from infesting the preferably preservative-free fluid. Particularly the filter can be used as a protective device. This prevents germs from infesting the fluid during the service life of the atomizer even when the atomizer is used several times.

Description

[0001] The present invention relates to an atomizer according to the preamble of claim 1.

[0002] The starting point of the present invention is an atomizer in the form of an inhaler offered under the brand name RESPIMAT ®<, as described in the basic principle in WO 91 / 14468 A1 and in a specific embodiment in WO 97 / 12687 A1 ( Fig. 6a, 6b ) as well as in Fig. 1 and 2 The atomizer comprises a reservoir for a fluid to be atomized, an insertable, rigid container with an inner bag containing the fluid, and a pressure generator with a drive spring for conveying and atomizing the fluid.

[0003] A particular problem with multiple uses of the nebulizer is that the fluid can become contaminated over time. Preservatives have traditionally been used to prevent contamination. However, due to increasing allergies, intolerances, and incompatibilities with active ingredients or excipients, or with nebulizer components, etc., it is desirable to no longer use preservatives.

[0004] WO 03 / 002265 A1 relates to a propellant-free nebulizer for the ophthalmic application of preservative-free liquids. It describes a nebulizer in which the application solution is dispensed from a reservoir bottle via a pump attachment with an eye adapter. The pump attachment has an opening, closed in the rest position by a ball valve, through which liquid can be pumped from the reservoir bottle into a pressure chamber, and a riser tube leading from the pressure chamber to the nozzle. A pressure control valve is located in the riser tube. The pressure chamber is formed by a pressure cylinder and a piston with an axial pump channel, with the piston being held against a stop by a spring in the rest position. To equalize the pressure in the reservoir after the liquid has been dispensed, points are provided through which outside air can enter the reservoir.Along the airway, means are provided to sterilize the incoming air, such as sterility filters, only for air-permeable membranes or oligodynamically active substances.

[0005] WO97 / 36690 A1 relates to an antibacterial device for spraying liquid from a container. A pump with a nozzle is arranged on the container. Above this, a cap is arranged with an internal channel extending between the nozzle and a cavity with a spray outlet. A valve is located in the cavity. On the outside of the cap is a shoulder that is pressed down to operate the pump.

[0006] WO 03 / 002045 A1 relates to a propellant-free nebulizer for applying liquids to the cornea or the conjunctival tissue of the eye.

[0007] The present invention is based on the object of providing an atomizer wherein the use of preservatives and / or contamination of the fluid to be atomized can be avoided or at least reduced.

[0008] The above object is achieved by an atomizer according to claim 1. Advantageous further developments are the subject of the subclaims.

[0009] Further advantages, features, properties, and aspects of the present invention will become apparent from the claims and the following description of preferred embodiments with reference to the drawings. It shows: Fig. 1a schematic section of a known atomizer in the unclamped state; Fig. 2a schematic, rotated by 90° with respect to Fig. 1rotated section of the known atomizer in the tensioned state; Fig. 3 a schematic section of a proposed atomizer according to a first embodiment in a delivery state with installed, closed container; Fig. 4 a schematic section of the atomizer according to Fig. 3 in the activated state or with the container open; Fig. 5 a schematic, partial section of the atomizer according to Fig. 3 ; Fig. 6one to Fig. 5 corresponding section of a second embodiment of the atomizer; Fig. 7 a Fig. 5 corresponding section of a third embodiment of the atomizer; Fig. 8 a schematic plan view of a proposed filter in the open state; Fig. 9 a partial enlargement of Fig. 8 ; Fig. 10 a section of the filter along the line XX of Fig. 8 of the filter in the closed state; Fig. 11 a partial enlargement of Fig. 10; and Fig. 12 a perspective view of a section of the open filter according to Fig. 8 .

[0010] In the figures, the same reference numerals are used for identical or similar parts, whereby corresponding or comparable properties and advantages are achieved, even if a repeated description is omitted.

[0011] Fig. 1 and 2 show a known atomizer 1 for atomizing a fluid 2, in particular a highly effective drug or the like, in a schematic representation in the untensioned state ( Fig. 1 ) and tensioned state ( Fig. 2 ). The atomizer 1 is designed in particular as a portable inhaler and preferably operates without propellant gas.

[0012] When the fluid 2, preferably a liquid, in particular a medicament, is atomized, a preferably respirable aerosol 14 ( Fig. 1) is formed, which can be inhaled or inhaled by a user or patient (not shown). Inhalation usually occurs at least once a day, especially several times a day, preferably at predetermined intervals, depending in particular on the patient's illness.

[0013] The known atomizer 1 comprises a preferably insertable and, in particular, replaceable container 3 containing the fluid 2. The container 3 thus forms a reservoir for the fluid 2 to be atomized. The container 3 preferably contains a sufficient amount of fluid 2 or active ingredient for several doses of the fluid 2, for example, to provide up to 200 dosage units (doses), thus enabling, for example, up to 200 atomizations or applications. A typical container 3, as disclosed in WO 96 / 06011 A1, holds a volume of approximately 2 to 10 ml.

[0014] The container 3 is preferably essentially cylindrical or cartridge-like and can be inserted into the atomizer 1 from below after opening it and can be replaced if necessary. It is preferably rigid, in particular with the fluid 2 being contained in a collapsible bag 4 in the container 3.

[0015] The atomizer 1 further comprises a conveying device, in particular a pressure generator 5, for conveying and atomizing the fluid 2, in particular in each case in a predetermined, possibly adjustable, dosage amount.

[0016] The atomizer 1 or pressure generator 5 has in particular a holder 6 for the container 3, an associated drive spring 7, only partially shown, preferably with a locking element 8 that can be manually operated for unlocking, a conveyor tube 9, preferably designed as a capillary, with an optional valve, in particular a check valve 10, a pressure chamber 11 and / or a discharge nozzle 12, in particular in the region of a mouthpiece 13.

[0017] The container 3 is secured in the atomizer 1 via the holder 6, particularly by clamping or locking, such that the delivery tube 9 is immersed in the container 3. The holder 6 can be designed such that the container 3 can be replaced.

[0018] When the drive spring 7 is axially tensioned, the holder 6 with the container 3 and the delivery pipe 9 is moved downwards in the illustrations and fluid 2 is sucked from the container 3 into the pressure chamber 11 of the pressure generator 5 via the check valve 10.

[0019] During the subsequent release after actuation of the locking element 8, the fluid 2 in the pressure chamber 11 is pressurized by the conveyor tube 9 being moved upwards again by relaxing the drive spring 7, with the check valve 10 now closed, and now acting as a pressure piston. This pressure expels the fluid 2 through the discharge nozzle 12, where it is atomized into the preferably respirable aerosol 14, as shown in Fig. 1 indicated.

[0020] The user or patient, not shown, can inhale the aerosol 14, wherein supply air can preferably be sucked into the mouthpiece 13 via at least one supply air opening 15.

[0021] The atomizer 1 has in particular a housing upper part 16 and a rotatable inner part 17 ( Fig. 2 ) with an upper part 17a and a lower part 17b ( Fig. 1 ), wherein a housing part 18, in particular manually operable, is detachably fastened, in particular plugged onto the inner part 17, preferably by means of a holding element 19. For inserting and / or replacing the container 3, the housing part 18 is detachable from the atomizer 1. The housing part 18 preferably forms a cap-like housing lower part and / or engages around or over a lower free end region of the container 3.

[0022] The housing part 18 can be rotated against the upper housing part 16, taking with it the lower part 17b of the inner part 17 in the illustration. As a result, the drive spring 7 is tensioned in the axial direction via a gear (not shown) acting on the holder 6. With the tensioning, the container 3 is moved axially downwards or with its end region (further) into the housing part 18 or towards its front end, until the container 3 has a Fig. 2 indicated end position. In this state, the drive spring 7 is tensioned.

[0023] When clamping for the first time, the container 3 is preferably pierced or opened at the bottom. In particular, an axially acting spring 20 arranged in the housing part 18 comes into contact with the container bottom 21, which, with a piercing element 22, pierces the container 3 or a bottom-side seal during the first installation for ventilation.

[0024] During the atomization process, the container 3 is moved back to its original position by the drive spring 7.

[0025] The container 3 therefore performs a lifting movement during the clamping process and during the atomization process.

[0026] As a precaution, reference is made to the complete disclosure content of both WO 91 / 14468 A1 and WO 97 / 12687 A1. In general, the disclosure therein preferably relates to an atomizer with a spring pressure of 5 to 60 MPa, preferably 10 to 50 MPa on the fluid, with a fluid volume of 10 to 50 µl, preferably 10 to 20 µl, most preferably about 15 µl, delivered per stroke. The fluid is converted into an aerosol whose droplets have an aerodynamic diameter of up to 20 µm, preferably 3 to 10 µm. Furthermore, the disclosure therein preferably relates to an atomizer with a cylindrical shape and a size of approximately 9 cm to approximately 15 cm in length and approximately 2 cm to approximately 5 cm in width, as well as with a nozzle jet angle of 20° to 160°, preferably 80° to 100°. Such values ​​are also considered particularly preferred values ​​for the atomizer according to the teachings of the present invention.

[0027] The structure and functioning of several embodiments of the proposed atomizer 1 are explained in more detail below, with reference being made to the further, in particular only schematic and not to scale, figures and only essential differences compared to the atomizer 1 according to Fig. 1 and 2 The statements on Fig. 1 and 2 apply accordingly or in addition, whereby any combination of features of the atomizer 1 according to Fig. 1 and 2 and the atomizer 1 according to the embodiments described below or among each other.

[0028] Fig. 3 and 4 show in schematic sections the proposed atomizer 1 according to a first embodiment. Fig. 3 shows the delivery condition with closed and especially sealed container 3. Fig. 4shows the activated state, i.e. with container 3 already open.

[0029] Fig. 3 and 4 show the atomizer 1 with a cap-like, optional cover 23, which covers or closes the mouthpiece 13 and, in particular, the air inlet openings 15 when the atomizer 1 is not in use. The cover 23 can be removed, opened, or otherwise removed or opened for use of the atomizer 1, for example.

[0030] Preferably, the (still) closed container 3 is already arranged in the atomizer 1 in the delivery state 1, as shown in Fig. 3shown. In the closed state, in the illustrated embodiments, in particular a top-side, outer seal 24 of the container 3 and / or a septum 25 arranged inside the container 3, a membrane, a plastic closure, or the like is / are not yet opened. Furthermore, in the closed state, in the illustrated embodiment, a preferably bottom-side ventilation opening 26 of the container 3, which can be opened by means of the piercing element 22, is closed, i.e., not yet pierced. It should be noted that, depending on the respective design, the container 3 may also have fewer and / or different opening options.

[0031] The atomizer 1 is preferably designed such that the container 3 is or can be opened within the atomizer 1 before or upon first use of the atomizer 1. Opening of the container 3 occurs, in particular, when the seal 24 and the septum 25 or the like are open. This is also referred to here as the activated state. The piercing or opening of the ventilation opening 26 can occur separately, in particular only later upon (first) tensioning of the atomizer 1.

[0032] According to the proposal, the container 3 is opened in particular by a conveying element, in particular the conveying tube 9 or the like, preferably by piercing the container 3 or inserting it into the container 3. By corresponding relative movement, in particular in the longitudinal direction or lifting direction of the container 3 relative to the conveying tube 9, the conveying tube 9 pierces the seal 24 and is inserted through the septum 25 into the interior of the container 3, in particular into the bag 4, whereby the container 3 is opened, namely a fluid connection is formed for the outlet of the fluid 2 from the container 3. The container 3 is therefore opened in particular at the head end.

[0033] During the normal clamping and atomization strokes, the container 3 is then preferably moved together with the conveying element or conveying pipe 9 by means of the holder 6, whereby the established fluid connection is maintained, so that the container 3 preferably always remains open.

[0034] The already mentioned, preferably bottom-side ventilation by opening the ventilation opening 26, can take place before, during or after the aforementioned, in particular head-side opening of the container 3, depending on the embodiment or requirement.

[0035] In the first embodiment, the container 3 is pre-installed, and the housing part 18 is not fully axially pushed on in the delivery state. Rather, a securing part 27, for example, is arranged between the housing part 18 and the upper housing part 16, so that the housing part or lower part 18 is sufficiently spaced from the upper housing part 16 to be able to hold the (still) closed container 3 axially spaced from the conveyor pipe 9.

[0036] In the non-activated, retracted state, the housing part 18 is preferably held captively and, in particular, non-releasably by at least one locking arm 28 or the like arranged on the upper housing part 16 or inner part 17. The locking arm 28 preferably engages with a locking lug 29 in a locking recess 30 in the housing part 18, thereby positively securing the housing part 18 against complete axial removal. However, other design solutions are also possible.

[0037] In particular, the housing part or lower part 18 of the atomizer 1 can no longer be detached from the atomizer 1 after the first (partial) axial sliding on, i.e. the atomizer 1 can no longer be opened, so that the container 3 cannot be replaced, in particular cannot be removed again.

[0038] The security part 27 is, for example, essentially hollow-cylindrical and arranged axially between the housing part 18 and the upper housing part 16. In order to activate the atomizer 1, i.e., to slide the housing part 18 fully axially open and thereby open the container 3, the security part 27 must first be removed or overcome. In particular, the security part 27 is designed in the manner of a banderol or the like, for example made of plastic, and can be manually opened, removed, overcome, broken, cut, or destroyed. The security part 27 can alternatively or simultaneously form or represent a tamper-evident seal. However, other designs of the security part 27 are also possible, for example in the form of a security tab or the like. Any other suitable security device can be used instead of the security part 27.For example, it is possible that the housing part 18 must first be rotated slightly before it can then be (fully) pushed axially. Possible implementations of the securing device are disclosed in particular in WO 2006 / 125577 A1.

[0039] After or upon removal or overcoming of the safety part 27 or any other safety device, a user (not shown) can completely slide the housing part 18 open in the axial direction and thereby bring about the activated state of the atomizer 1, namely open the container 3 by inserting the conveying element or conveying tube 9. Fig. 4 shows this activated state with the housing part 18 completely pushed on. In this pushed-on state, the housing part 18 is preferably again secured or held in a form-fitting manner, in particular by engagement of the locking arm 28 or the locking lug 29 in a corresponding, further locking recess 31 or by another mechanical securing means.

[0040] Fig. 4 shows the atomizer 1 or the container 3 in the activated state, the container 3 is already open and the housing part 18 is pushed on completely axially. In order to bring the holder 6 into engagement with the container 3 at the head end and then to be able to move the container 3 for the clamping and compression strokes, it may be necessary to clamp the atomizer 1 for the first time. During this clamping process, the holder 6, together with the conveyor tube 9, is moved axially towards or into the housing part 18, whereby the holder 6 is brought into engagement with the container 3 and preferably also the container 3 is pressed against the piercing element 22 in the region of the bottom of the housing part 18, thereby piercing or opening the ventilation opening 26. Fig. 4shows the atomizer 1 in the relaxed state, specifically after the first atomization. The holder 6 is engaged with the container 3, and the delivery tube 9 is fully inserted into the container 3.

[0041] In the Fig. 3 The atomizer 1 can be stored in the delivery state shown, i.e., with the container 3 (still) sealed. In particular, the closed seal 24 ensures that any solvent contained in the fluid 2 cannot escape, or at most, only to a very small extent.

[0042] To prevent unwanted opening of the container 3, in particular of the seal 24 or the ventilation opening 26, in the delivery state of the atomizer 1, the atomizer 1 preferably has a transport lock (not shown). The transport lock prevents, for example, by friction, force, or form-fitting, the container 3 from moving axially in an undesired manner within the atomizer 1—for example, during transport, if the atomizer 1 accidentally falls down, or the like—and thus from opening unintentionally.

[0043] Possibilities for securing the container 3 during transport are disclosed in particular in WO 2006 / 125577 A1.

[0044] It should be noted that the opening of the container 3 is preferably carried out exclusively by mechanical action and / or manual operation. However, additionally or alternatively, opening by other means, for example chemically, electrically, magnetically, pneumatically, hydraulically, or the like, is also possible.

[0045] The proposed atomizer 1 is activated after the container 3 or housing part 18 has been fully pushed on axially and is operated according to the Fig. 1 and 2 shown atomizer 1 can be used.

[0046] In contrast to stand-alone devices or the like, the proposed atomizer 1 is preferably designed to be portable, in particular it is a mobile handheld device.

[0047] The proposed atomizer operates purely mechanically. However, atomizer 1 can, in principle, also operate in any other way. In particular, the term "conveying device" or "pressure generator" should be understood very broadly. For example, the pressure required for dispensing and atomization can also be generated by propellant gas, a pump, or any other suitable means.

[0048] The proposed atomizer 1 is designed in particular for the short-term atomization of the fluid 2, for example, for one or two breaths. However, it can also be designed or used for longer or continuous atomization.

[0049] The atomizer 1 preferably has a protective device 32 to prevent or at least reduce possible contamination of the fluid 2.

[0050] In the first embodiment, the protective device 32 has a germ-proof, in particular sterile covering, preferably a bag 33, for receiving the atomizer 1 and preferably also the container 3 in the delivery state, as shown in Fig. 3 The wrapping or bag 33 is preferably made of film or plastic material and / or is at least partially transparent. The wrapping or bag 33 is preferably gas-tight.

[0051] The envelope or bag 33 preferably surrounds the atomizer 1 relatively loosely and / or is in particular flexible or elastic, so that the atomizer or container 3 can preferably be activated while the envelope is still closed.

[0052] After activation, the casing can be opened, especially torn or cut, and removed so that the atomizer can then be used normally. Fig. 4bag 33 has already been removed.

[0053] The protective device 32 or the covering ensures, in particular, that the atomizer 1 and the container 3 can be stored germ-tight and, in particular, sterile for a very long time.

[0054] According to a first method variant, the already sterile container 3 is inserted into the sterile nebulizer 1 under sterile conditions, and the nebulizer 1 is then enclosed or enclosed under sterile conditions by the equally sterile wrapping. Subsequent or additional sterilization is then no longer necessary, but is possible.

[0055] According to a second method variant, sterilization occurs only after the container 3 has been inserted into the atomizer 1 and, if necessary, even after the atomizer 1 is enclosed by the sheath. In this case, the atomizer 1, container 3, and / or the sheath do not need to be sterilized beforehand and / or do not need to be operated under sterile conditions.

[0056] Sterilization can be achieved, in particular, by radiation (e.g., microwave, UV, X-ray, or gamma radiation) and / or gas (e.g., ethylene oxide). If necessary, it may also be sufficient to fill the packaging with a sterilizing gas during sealing.

[0057] Furthermore, the protective device 32 can alternatively or additionally have a germ-tight receiving space 34 for the container 3 in the atomizer 1. In particular, the receiving space 34 is formed by the atomizer 1, particularly preferably by the housing part 18, which in this case can then be attached in a germ-tight manner. However, other design solutions are also possible here.

[0058] Sterilization then takes place, as with bag 33, preferably before, during and / or after closing.

[0059] According to a further embodiment, the protective device 32 can have a contact section 35 for the fluid 2 that kills bacteria or other germs or has an antibacterial effect. The contact section 35 is in Fig. 5 which shows a schematic, enlarged section of a part of the atomizer 1, in particular an outlet or nozzle assembly 36.

[0060] The contact section 35 has a particularly oligodynamic effect. Preferably, the contact section 35 contains or is made of silver and / or copper, such alloys, mixtures, or the like. Alternatively or additionally, the contact section 35 can also contain or be made of activated carbon.

[0061] The contact section 35 is preferably arranged in or formed from a section of the fluid path, in particular in the outlet or nozzle assembly 36, in an outlet channel 37 or in the conveying device or the pressure generator 5 or in or on the container 3.

[0062] Particularly preferably, the contact section 35 is arranged near the discharge nozzle 12 or another outlet and / or downstream of the pressure chamber 11.

[0063] The contact section 35 can, if necessary, alternatively or additionally also be arranged in the pressure chamber 11. Alternatively or additionally, the contact section 35 can also be arranged on the container 3, in particular at its outlet and / or on or in the conveyor pipe 9 or the like.

[0064] In principle, however, the contact section 35 can also be arranged at other suitable locations. If necessary, several contact sections 35 can also be provided along the fluid path.

[0065] In the illustrated example, the contact section 35 forms, in particular, part of a wall of a channel, such as the outlet channel 37. For this purpose, the contact section 35 is, in particular, hollow-cylindrical or provided with a corresponding bore, opening, or the like. However, other design solutions are also possible. In particular, it is also possible for the contact section 35 to form a flat side or opposing flat sides of a very flat channel section in order to achieve the largest possible contact area between the contact section 35 on the one hand and the fluid 2 on the other.

[0066] The contact section 35 can generally be formed by a component or a section of a component of the atomizer 1 or by a coating at least in some areas.

[0067] Alternatively or additionally, the contact section 35 can also be formed by a material admixture and / or in particular discrete particles or other, in particular oligodynamic or antibacterial particles, or such particles can be integrated into a material (e.g. metal, composite material, plastic or ceramic) so that the particles can interact with the fluid 2. Alternatively or additionally, the particles can also be arranged in a surface area or form a coating. According to one embodiment, the conveying element or conveying pipe 9 is made of and / or coated with a corresponding, antibacterial material, such as a silver-containing alloy. Alternatively or additionally, plastic surfaces can also be coated accordingly to form the contact section 35.

[0068] According to one embodiment variant, the contact section 35 is formed on or in the discharge nozzle 12 or outlet or nozzle assembly 36.

[0069] Particularly preferably, the contact section 35 is formed or arranged in a residual drop area on the outside of the nozzle 12 or outlet or nozzle assembly 36.

[0070] Alternatively or additionally, the contact section 35 can also be integrated into a filter or formed thereby.

[0071] According to a particularly preferred embodiment, all metal components of the atomizer 1 that come into contact with the fluid 2 are made of and / or coated with at least substantially the same material and / or material having at least substantially the same electronegativity.

[0072] The outlet or nozzle assembly 36 preferably has the outlet channel 37 with the adjoining discharge nozzle 12. Particularly preferably, the outlet or nozzle assembly 36 is made in one piece—optionally with the exception of the contact section 35—particularly preferably from ceramic, sintered material, silicon, glass, or the like.

[0073] The outlet or nozzle assembly 36 is preferably fluidically connected to the pressure chamber 11 on the inlet side. It is installed, in particular, within the mouthpiece 13 in such a way that the desired atomization of the fluid 2 as an aerosol 14 occurs in and / or out of the mouthpiece 13 during fluid discharge.

[0074] Alternatively or additionally, the cover 23 can also be designed as a protective device 32. In this case, the cover 23 is preferably designed to be germ-tight in order to prevent or at least reduce possible contamination of the fluid 2 via the discharge nozzle 12. If necessary, the cover 23 can also be placed directly on the discharge nozzle 12 or the outlet or nozzle assembly 36. Alternatively or additionally, the cover 23, particularly in this area, or the outlet or nozzle assembly 36 in this area, can be designed to be oligodynamic, or can have or form a contact section 35 there in the sense already mentioned.

[0075] In the following, a second embodiment of the proposed atomizer 1 is described with reference to Fig. 6described, with particular reference to only essential differences compared to the first embodiment. The previous statements and explanations therefore apply correspondingly or in addition.

[0076] Fig. 6 shows in a Fig. 5 corresponding illustration shows a schematic section, also not to scale, of the outlet or nozzle assembly 36 of the atomizer 1 according to the second embodiment.

[0077] In the second embodiment, the protective device 32, in addition to or alternatively to the possibilities already described, has a lockable valve 38 for preventing or at least minimizing contamination of the fluid 2 in the container 3, in the conveying element, such as the conveying pipe 9, in the pressure chamber 11, in the outlet channel 37 and / or in another fluid-conducting section, or generally in the conveying device or the pressure generator 5. The valve 38 blocks, in particular, an associated channel, such as the outlet channel 37, in order to prevent or at least minimize the penetration of germs.

[0078] In the example shown, valve 38 is assigned to the outlet or nozzle assembly 36, specifically, it is installed therein. However, other design solutions are also possible.

[0079] The valve 38 is preferably designed to close automatically, in particular by spring force. For example, a movable valve element 39 is moved by means of a closing spring 40 into the Fig. 6 shown closed position in which it blocks the outlet channel 37.

[0080] The valve 38 is preferably openable by the applied fluid pressure. In the illustrated example, a connecting channel 41 is provided for this purpose, branching off from the outlet channel 37 upstream of the valve 38, so that the valve element 39 can be opened against the force of the closing spring 40 when the appropriate fluid pressure is present. However, other design solutions are also possible.

[0081] In particular, the valve 38 can be designed as a one-way or check valve.

[0082] In the illustrated example, valve 38 preferably operates exclusively mechanically or hydraulically. However, other design solutions are also possible. For example, valve 38 can also operate electrically, electromagnetically, piezoelectrically, pneumatically, or in any other suitable manner, and in particular, can be opened and / or closed.

[0083] The valve 38 is preferably designed to block the outlet channel 37 or another channel section for guiding the fluid 2. However, according to a variant not shown, it may also be sufficient to interrupt the fluid flow or the fluid column, for example, by means of a corresponding capillary stop or the like, so that, for example, two separate fluid regions or columns are formed that are not in direct fluidic contact with one another, thereby preventing or at least hindering the transmission of germs between them.

[0084] Like the contact section 35, the valve 38 can be arranged at various locations. In particular, the valve 38 is arranged directly adjacent to or upstream of the discharge nozzle 12 and / or downstream of the pressure chamber 11. Additionally or alternatively, the valve 38 can also be arranged on the container 3, in particular to block its outlet.

[0085] If necessary, the contact section 35 can also be integrated into the valve 38 or vice versa.

[0086] The schematic, to the Figs. 5 and 6 corresponding cut according to Fig. 7 shows a third embodiment of the proposed atomizer 1. Again, only the outlet or nozzle assembly 36 is shown. The previous statements and explanations apply accordingly.

[0087] In the third embodiment, a filter 42 is provided as the protective device 32, in addition to or as an alternative to the options already described. The filter has only such fine passages 43 that it is at least essentially germ-tight. Germs such as bacteria or the like are therefore, at least for the most part, unable to pass through the passages 43.

[0088] The filter 42 is preferably arranged in the outlet channel 37 or another channel section, so that the fluid 2 must first necessarily pass through the filter 42, particularly immediately before being discharged via the discharge nozzle 12 or another outlet. The filter 42 can then—corresponding to the contact section 35 or valve 38—prevent or at least minimize unwanted penetration of germs on the outlet side or nozzle side.

[0089] In the illustrated example, the filter 42 is arranged downstream of the pressure chamber 11 or conveying device or a pump or the pressure generator 5 and / or upstream of the discharge nozzle 12.

[0090] The atomizer 1 can also have several discharge nozzles 12, as in Fig. 7 shown as an example. The discharge nozzles 12 are then connected either via a common channel or - as shown - via separate outlet channels 37' and 37", here in particular to the filter 42.

[0091] Fig. 8 to 12show a proposed filter 42, which can be used in particular as a protective device 32 in the proposed nebulizer 1—particularly preferably in the third embodiment, in particular integrated into the outlet or nozzle assembly 36—or in other nebulizers 1, inhalers, or the like. The filter 42 is intended or usable in particular to prevent or at least minimize the possible contamination of a fluid 2, preferably to be nebulized. However, the fluid 2 can also be dispensed in any other suitable manner.

[0092] Fig. 8 shows the open filter 42 in a plan view. Fig. 9 shows an enlarged section of Fig. 8 . Fig. 10 shows the closed filter 42 in a schematic section along the line XX of Fig. 8 . Fig. 11 shows an enlarged section of Fig. 10. Fig. 12shows a perspective view of a section of the filter 42 with uncovered passages 43.

[0093] The filter 42 has only such fine passages 43 that it is at least essentially germ-tight. The average or largest diameter d ( Fig. 12 ) or a largest cross-sectional extent of the passages 43 is about 0.3 µm or less.

[0094] The passages 43 are preferably substantially rectangular in cross-section. The maximum or average width b and / or the maximum or average height h and / or the maximum diameter d of the passages 43 is at most 0.3 µm or less. In the illustrated example, the widths b and the height h are each substantially 0.2 µm.

[0095] The passages 43 are preferably each longer than their maximum diameter d. This contributes to high stability and, in particular, high pressure resistance of the filter 42. In particular, their length 1 is approximately 1 µm to 5 µm.

[0096] The filter 42 is preferably constructed from a piece of material 44 and a cover element 45. Fig. 8 shows the filter 42 or the material piece 44 in plan view without the cover element 45. The section according to Fig. 10 shows the filter 42 or the piece of material 44 with the cover element 45.

[0097] In the example shown, the passages 43 are cut out starting from a flat side of the piece of material 44, as can be seen in particular in Fig. 10 indicated.

[0098] Preferably, the passages 43 are formed between the material piece 44 and the cover element 45. However, other design solutions are also possible.

[0099] In the illustrated example, the piece of material 44 is cut out starting from a flat side and structured as desired, in particular by etching, for example, as known from semiconductor technology, by embossing, by laser processing, and / or by any other suitable processing method. For example, larger areas can also be milled away. Machining accuracy is essential, as very fine, defined openings 43 are formed.

[0100] In the illustrated example, the passages 43 are preferably located essentially in a plane that runs parallel to the flow through the passages 43.

[0101] The passages 43 are preferably laterally limited or covered by a common cover, namely the cover element 45.

[0102] The passages 43 are preferably arranged next to one another in a line and in particular run in a meandering manner ( Fig. 8) or zigzag or in any other suitable manner.

[0103] In the illustrated example, the filter 42 preferably has an inlet 46 and an adjoining distribution chamber 47. A filter structure 48 with the passages 43 separates the distribution chamber 47 from a collection chamber 49 located on the other side of the filter structure 48, which is connected to an outlet 50 of the filter 42.

[0104] The inlet 46 is preferably connected to the pressure chamber 11 or the outlet channel 37. The outlet 50 is preferably connected to the outlet channel 37 or the discharge nozzle 12. In particular, the filter 42 is connected in such a way that the Fig. 8 to 12 Fluid 2 (not shown) must necessarily pass through the filter 42 during discharge, i.e. must necessarily flow through the passages 43.

[0105] In the illustrated example, the passages 43, the inlet 46, the distribution chamber 47, the collection chamber 49 and / or the outlet 50 are preferably formed as depressions in the piece of material 44 and in particular are surrounded by a remaining edge of the piece of material 44, via which the connection to the cover element 45 is made.

[0106] The filter structure 48 extends in particular essentially in a meandering, zigzag, linear or any other suitable manner, particularly preferably in such a way that as many passages 43 as possible can be formed.

[0107] In the illustrated example, the filter 42 has, for example, more than 1,000 passages 43 with a relatively small total volume and, in particular, a very small absorption volume of fluid 2 (preferably about 1 µl or less).

[0108] The large number of passages 43 connected in parallel leads to a comparatively or at least sufficiently low flow resistance.

[0109] To achieve high stability of the filter structure 48 with the passages 43, the filter structure 48 initially has a preferably rib-like or web-like elevation 51 that rises from the bottom of the distribution chamber 47 or collection chamber 49 toward the cover element 45. The elevation 51 has, for example, a width B of a few µm, approximately 5 µm in the illustrated example. The elevation 51 is, in particular, continuous, continuous, and / or linear and runs, in particular, in a meandering, zigzag, linear, or similar manner, corresponding to the filter structure 48.

[0110] Arranged on the elevation 51 is a preferably narrower, in particular web-, rib-, or strip-like elevation 52, which runs along the elevation 51 and has, for example, a width reduced to approximately 5 to 50% compared to the elevation 51. The height and width of the elevation 52 are, for example, each approximately 1 µm. Depending on the desired length of the passages 43, the width can also be, for example, up to 5 µm. The same applies to the height for the possible variation of the depth or cross-section of the passages 43.

[0111] Starting from the flat side of the elevation 52, the passages 43 are formed in particular by grooves or groove-like recesses or depressions in the elevation 52.

[0112] The center-to-center distance of the passages 43 is, for example, approximately 1 µm or the width or thickness of the elevation 52. However, other dimensions are also possible.

[0113] In the representation according to Fig. 8The flat side of the material piece 44 and the flat side of the raised portion 52 face the viewer. The openings 43 are still open on the flat side—i.e., along the length—and are preferably first covered by the cover element 45 or another cover and then closed laterally. This significantly facilitates manufacturing with high precision and tight tolerances—particularly through etching. However, other design solutions are also possible.

[0114] In order to further improve the special connection with the cover element 45 and / or to further increase the stability of the filter structure 48 in the filter 42, in particular with regard to a particularly high pressure stability and other strength of the filter 42, optional support structures 53 can be provided, as in Fig. 8 indicated. The support structures 53 extend from the elevation 51 next to the elevation 52 to the cover element 45, to which they are preferably also connectable. In Fig. 10The optional support structures 53 are not shown for simplification reasons.

[0115] Solid material or plate material is preferably used as the starting material for the material piece 44.

[0116] The piece of material 44 is preferably made of silicon or another suitable material, for example, sintered material, ceramic, glass, or the like. The cover element 45 is particularly made of the same material or another suitable material, preferably glass. The material piece 44 and the cover element 45 are connected to one another, in particular, by bonding or welding. However, any other suitable type of connection, such as a sandwich construction, or the like, is also possible.

[0117] In a particularly preferred embodiment, a plate piece (not shown), in particular a silicon wafer, is used, from which a plurality of material pieces 44 for a plurality of filters 42 are produced. Before being divided into individual material pieces 44 or filters 42, the structures, in particular depressions, for the plurality of material pieces 44 are preferably first produced starting from a flat side of the plate piece. This is done in particular by the production or etching of fine structures customary in semiconductor production, so that reference may be made in this regard to the prior art for the etching of silicon or the like.

[0118] Particularly preferably, the cover element 45, like the material piece 44, is produced from a single plate piece that is divided or separated into a plurality of cover elements 45. For the production of the material piece 44, a silicon wafer is particularly preferably used as the plate piece, as already explained. A silicon wafer or another wafer, a glass pane, or the like can also be used for the plate piece for producing the cover elements 45.

[0119] If a plate piece is used for both the production of the material pieces 44 and the production of the cover elements 45, it is particularly preferred to connect the plate pieces to one another before disassembling them into the individual material pieces 44 or cover element 45. This significantly simplifies assembly and positioning.

[0120] If necessary, the filter 42 can also have several—i.e., two or more—rows of passages 43 arranged one behind the other. The rows can, for example, run parallel to one another. For this purpose, several—i.e., two or more—elevations 52 can be provided on a raised portion 51—in particular, running parallel and / or spaced from one another. Alternatively or additionally, several—in particular, two or more—elevations 51 can be arranged one behind the other or in series—in particular, running parallel and / or spaced from one another—each with at least one raised portion 52.

[0121] In principle, the filter 42 can also be combined with another filter, such as a pre-filter or the like, i.e. in particular connected in series.

[0122] The proposed filter 42 can also be used for the outlet or nozzle assembly 36 - for example according to the third embodiment according to Fig. 7 - be used.

[0123] In particular, it is possible to design the filter 42 as a structural unit with the discharge nozzle 12 or the outlet or nozzle assembly 36. This significantly simplifies manufacture and assembly. Particularly preferably, the discharge nozzle 12, or optionally several discharge nozzles 12, are then manufactured together with the associated filter 42, most preferably in the manner described above from the piece of material 44 and the cover element 45, or in any other suitable manner.

[0124] However, the proposed solution can be used not only with the nebulizers 1 described in detail here, but also with other nebulizers or inhalers, related containers 3 or the like.

[0125] In particular, the proposed filter 42 can also be used for other purposes, for example, in the purification of the fluid 2, generally in the separation of germs, bacteria, cells, or the like. In particular, the filter 42 is suitable and designed for small or very small quantities in the µl range.

[0126] In general, the atomizer 1 may also have another filter 42, for example made of porous material, in order to protect the discharge nozzle 12 or the outlet or nozzle assembly 36 or the outlet channel 37 from possible clogging.

[0127] Individual features, aspects or properties of the various embodiments can also be combined with one another as desired or used in other nebulizers, inhalers or the like.

[0128] The fluid 2 preferably contains ethanol and in particular contains ethanol as a solvent.

[0129] Alternatively or additionally, the fluid 2 may contain EDTA (ethylenediaminetetraacetic acid) or its salts as complexing agents.

[0130] Preferably, the fluid 2 is a liquid, as already mentioned, in particular an aqueous, ethanolic, or aqueous / ethanolic pharmaceutical preparation. However, it may also be another pharmaceutical preparation, a suspension, or the like.

[0131] Preferred compounds, components and / or formulations of the preferably medical fluid 2 are listed below. As already mentioned, these can be aqueous or non-aqueous solutions, mixtures, ethanol-containing or solvent-free formulations or the like. Particularly preferred are: The compounds mentioned below can be used alone or in combination in the device according to the invention. Wa pharmacologically active substance and (for example) selected from the group consisting of beta-mimetics, and combinations of W and used in the device according to the invention. Examples of combinations of W would be: W represents a beta-mimetic, combined with an anticholinergic, corticosteroid, PDE4 inhibitor, EGFR inhibitor or LTD4 antagonist, W represents an anticholinergic, combined with a beta-mimetic, corticosteroids, PDE4 inhibitors, EGFR inhibitors or LTD4 antagonists, W represents a corticosteroid combined with a PDE4 inhibitor, EGFR inhibitor or LTD4 antagonist W represents a PDE4 inhibitor combined with an EGFR inhibitor or LTD4 antagonist W represents an EGFR inhibitor combined with an LTD4 antagonist.

[0132] Betamimetics used are preferably compounds selected from the group consisting of Albuterol, Arformoterol, Bambuterol, Bitolterol, Broxaterol, Carbuterol, Clenbuterol, Fenoterol, Formoterol, Hexoprenaline, Ibuterol, Isoetharine, Isoprenaline, Levosalbutamol, Mabuterol, Meluadrine, Metaproterenol, Orciprenaline, Pirbuterol, Procaterol, Reproterol, Rimiterol, Ritodrine, Salmefamol, Salmeterol, Soterenol, Sulphonterol, Terbutaline, Tiaramide, Tolubuterol, Zinterol, CHF-1035, HO-KU-81, KUL-1248 and 3-(4-{6-[2-Hydroxy-2-(4-hydroxy-3-hydroxymethyl-phenyl)-ethylamino]-hexyloxy}-butyl)-benzyl-sulfonamid 5-[2-(5,6-Diethyl-indan-2-ylamino)-1-hydroxy-ethyl]-8-hydroxy-1H-quinolin-2-on 4-Hydroxy-7-[2-{[2-{[3-(2-phenylethoxy)propyl]sulphonyl}ethyl]-amino}ethyl]-2(3H)-benzothiazolon 1-(2-Fluor-4-hydroxyphenyl)-2-[4-(1-benzimidazolyl)-2-methyl-2-butylamino]ethanol 1-[3-(4-Methoxybenzyl-amino)-4-hydroxyphenyl]-2-[4-(1-benzimidazolyl)-2-methyl-2-butylamino]ethanol 1-[2H-5-hydroxy-3-oxo-4H-1,4-benzoxazin-8-yl]-2-[3-(4-N,N-dimethylaminophenyl)-2-methyl-2-propylamino]ethanol 1-[2H-5-hydroxy-3-oxo-4H-1,4-benzoxazin-8-yl]-2-[3-(4-methoxyphenyl)-2-methyl-2-propylamino]ethanol 1-[2H-5-hydroxy-3-oxo-4H-1,4-benzoxazin-8-yl]-2-[3-(4-n-butyloxyphenyl)-2-methyl-2-propylamino]ethanol 1-[2H-5-hydroxy-3-oxo-4H-1,4-benzoxazin-8-yl]-2-{4-[3-(4-methoxyphenyl)-1,2,4-triazol-3-yl]-2-methyl-2-butylamino}ethanol 5-Hydroxy-8-(1-hydroxy-2-isopropylaminobutyl)-2H-1,4-benzoxazin-3-(4H)-on 1-(4-Amino-3-chlor-5-trifluormethylphenyl)-2-tert.-butylamino)ethanol 6-Hydroxy-8-{1-hydroxy-2-[2-(4-methoxy-phenyl)-1,1-dimethyl-ethylamino]-ethyl}-4H-benzo[1,4]oxazin-3-on 6-Hydroxy-8-{1-hydroxy-2-[2-(4-phenoxy-essigsäureethylester)-1,1-dimethyl-ethylamino]-ethyl}-4H-benzo[1,4]oxazin-3-on 6-Hydroxy-8-{1-hydroxy-2-[2-(4-phenoxy-essigsäure)-1,1-dimethyl-ethylamino]-ethyl}-4H-benzo[1,4]oxazin-3-on 8-{2-[1,1-Dimethyl-2-(2,4,6-trimethylphenyl)-ethylamino]-1-hydroxy-ethyl}-6-hydroxy-4H-benzo[1,4]oxazin-3-on 6-Hydroxy-8-{1-hydroxy-2-[2-(4-hydroxy-phenyl)-1,1-dimethyl-ethylamino]-ethyl}-4H-benzo[1,4]oxazin-3-on 6-Hydroxy-8-{1-hydroxy-2-[2-(4-isopropyl-phenyl)-1,1dimethyl-ethylamino]-ethyl}-4H-benzo[1,4]oxazin-3-on 8-{2-[2-(4-Ethyl-phenyl)-1,1-dimethyl-ethylamino]-1-hydroxy-ethyl}-6-hydroxy-4H-benzo[1,4]oxazin-3-on 8-{2-[2-(4-Ethoxy-phenyl)-1,1-dimethyl-ethylamino]-1-hydroxy-ethyl}-6-hydroxy-4H-benzo[1,4]oxazin-3-on 4-(4-{2-[2-Hydroxy-2-(6-hydroxy-3-oxo-3,4-dihydro-2H-benzo[1,4]oxazin-8-yl)-ethylamino]-2-methyl-propyl}-phenoxy)-buttersäure 8-{2-[2-(3,4-Difluor-phenyl)-1,1-dimethyl-ethylamino]-1-hydroxy-ethyl}-6-hydroxy-4H-benzo[1,4]oxazin-3-on 1-(4-Ethoxy-carbonylamino-3-cyano-5-fluorophenyl)-2-(tert.-butylamino)ethanol 2-Hydroxy-5-(1-hydroxy-2-{2-[4-(2-hydroxy-2-phenyl-ethylamino)-phenyl]-ethylamino}-ethyl)-benzaldehyd N-[2-Hydroxy-5-(1-hydroxy-2-{2-[4-(2-hydroxy-2-phenyl-ethylamino)-phenyl]-ethylamino}-ethyl)-phenyl]-formamid 8-Hydroxy-5-(1-hydroxy-2-{2-[4-(6-methoxy-biphenyl-3-ylamino)-phenyl]-ethylamino}-ethyl)-1H-quinolin-2-on 8-Hydroxy-5-[1-hydroxy-2-(6-phenethylamino-hexylamino)-ethyl]-1H-quinolin-2-on 5-[2-(2-{4-[4-(2-Amino-2-methyl-propoxy)-phenylamino]-phenyl}-ethylamino)-1-hydroxy-ethyl]-8-hydroxy-1H-quinolin-2-on [3-(4-{6-[2-Hydroxy-2-(4-hydroxy-3-hydroxymethyl-phenyl)-ethylamino]-hexyloxy}-butyl)-5-methyl-phenyl]-harnstoff 4-(2-{6-[2-(2,6-Dichloro-benzyloxy)-ethoxy]-hexylamino}-1-hydroxy-ethyl)-2-hydroxymethyl-phenol 3-(4-{6-[2-Hydroxy-2-(4-hydroxy-3-hydroxymethyl-phenyl)-ethylamino]-hexyloxy}-butyl)-benzylsulfonamid 3-(3-{7-[2-Hydroxy-2-(4-hydroxy-3-hydroxymethyl-phenyl)-ethylamino]-heptyloxy}-propyl)-benzylsulfonamid 4-(2-{6-[4-(3-Cyclopentanesulfonyl-phenyl)-butoxy]-hexylamino}-1-hydroxy-ethyl)-2-hydroxymethyl-phenol N-Adamantan-2-yl-2-(3-{2-[2-hydroxy-2-(4-hydroxy-3-hydroxymethyl-phenyl)-ethylamino]-propyl}-phenyl)-acetamid , optionally in the form of their racemates, enantiomers, diastereomers, and optionally in the form of their pharmacologically acceptable acid addition salts, solvates, or hydrates. According to the invention, the acid addition salts of the betamimetics are preferably selected from the group consisting of hydrochloride, hydrobromide, hydroiodide, hydrosulfate, hydrophosphate, hydromethanesulfonate, hydronitrate, hydromaleate, hydroacetate, hydrocitrate, hydrofumarate, hydrotartrate, hydrooxalate, hydrosuccinate, hydrobenzoate, and hydro-p-toluenesulfonate.

[0133] As anticholinergics, compounds are preferably used that are selected from the group consisting of tiotropium salts, preferably the bromide salt, oxitropium salts, preferably the bromide salt, flutropium salts, preferably the bromide salt, ipratropium salts, preferably the bromide salt, glycopyrronium salts, preferably the bromide salt, trospium salts, preferably the chloride salt, and tolterodine. In the above-mentioned salts, the cations represent the pharmacologically active components. The above-mentioned salts can preferably contain chloride, bromide, iodide, sulfate, phosphate, methanesulfonate, nitrate, maleate, acetate, citrate, fumarate, tartrate, oxalate, succinate, benzoate or p-toluenesulfonate as anions, with chloride, bromide, iodide, sulfate, methanesulfonate or p-toluenesulfonate being preferred as counterions. Of all the salts, chlorides, bromides, iodides and methanesulfonates are particularly preferred.

[0134] Also preferred anticholinergics are selected from the salts of the formula AC-1 wherein X -< is a singly negatively charged anion, preferably an anion selected from the group consisting of fluoride, chloride, bromide, iodide, sulfate, phosphate, methanesulfonate, nitrate, maleate, acetate, citrate, fumarate, tartrate, oxalate, succinate, benzoate and p-toluenesulfonate, preferably a singly negatively charged anion, particularly preferably an anion selected from the group consisting of fluoride, chloride, bromide, methanesulfonate and p-toluenesulfonate, especially preferably bromide, optionally in the form of their racemates, enantiomers or hydrates. Of particular importance are those drug combinations which contain the enantiomers of the formula AC-1s where X -< can have the meanings given above. Further preferred anticholinergics are selected from the salts of the formula AC-2 wherein R is either methyl or ethyl and wherein X -< can have the meanings given above. In an alternative embodiment, the compound of the formula AC-2 also in the form of the free base AC-2-base present.

[0135] Other compounds mentioned are: 2,2-Diphenylpropionic acid tropenol ester methobromide 2,2-Diphenylpropionic acid scopine ester methobromide 2-Fluoro-2,2-Diphenylacetic acid scopine ester methobromide 2-Fluoro-2,2-Diphenylacetic acid tropenol ester methobromide 3,3',4,4'-Tetrafluorobenzilic acid tropenol ester methobromide 3,3',4,4'-Tetrafluorobenzilic acid scopine ester methobromide 4,4'-Difluorobenzilic acid tropenol ester methobromide 4,4'-Difluorobenzilic acid scopine ester methobromide 3,3'-Difluorobenzilic acid tropenol ester methobromide 3,3'-Difluorobenzilic acid scopine ester methobromide 9-Hydroxy-fluorene-9-carboxylic acid tropenol ester methobromide 9-Fluoro-fluorene-9-carboxylic acid tropenol ester methobromide 9-Hydroxy-fluorene-9-carboxylic acid scopine ester methobromide 9-Fluoro-fluorene-9-carboxylic acid scopine ester methobromide 9-Methyl-fluorene-9-carboxylic acid tropenol ester methobromide 9-Methyl-fluorene-9-carboxylic acid scopine ester methobromide Benzilic acid cyclopropyltropine ester methobromide 2,2-Diphenylpropionic acid cyclopropyltropin ester methobromide 9-Hydroxy-xanthene-9-carboxylic acid cyclopropyltropin ester methobromide 9-Methyl-fluorene-9-carboxylic acid cyclopropyltropin ester methobromide 9-Methyl-xanthene-9-carboxylic acid cyclopropyltropin ester methobromide 9-Hydroxy-fluorene-9-carboxylic acid cyclopropyltropin ester methobromide 4,4'-Difluorobenzilic acid methyl ester cyclopropyltropin ester methobromide 9-Hydroxy-xanthene-9-carboxylic acid tropenol ester methobromide 9-Hydroxy-xanthene-9-carboxylic acid scopine ester methobromide 9-Methyl-xanthene-9-carboxylic acid tropenol ester methobromide 9-Methyl-xanthene-9-carboxylic acid scopine ester methobromide 9-Ethyl-xanthene-9-carboxylic acid tropenol ester methobromide 9-Difluoromethyl-xanthene-9-carboxylic acid tropenol ester methobromide 9-Hydroxymethyl-xanthene-9-carboxylic acid scopine ester methobromide,

[0136] The above-mentioned compounds can also be used in the context of the present invention as salts in which, instead of methobromide, the salts Metho-X are used, where X can have the meanings given above for X -<.

[0137] The corticosteroids used are preferably compounds selected from the group consisting of beclomethasone, betamethasone, budesonide, butixocort, ciclesonide, deflazacort, dexamethasone, etiprednol, flunisolide, fluticasone, loteprednol, mometasone, prednisolone, prednisone, rofleponide, triamcinolone, RPR-106541, NS-126, ST-26 and 6,9-Difluoro-17-[(2-furanylcarbonyl)oxy]-11-hydroxy-16-methyl-3-oxo-androsta-1,4-diene-17-carbothionic acid (S)-fluoromethyl ester (S)-(2-oxo-tetrahydro-furan-3S-yl)ester, 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-(2,2,3,3-tertamethylcyclopropylcarbonyl)oxy-androsta-1,4-diene-17β-carboxylic acid cyanomethyl ester optionally in the form of their racemates, enantiomers, or diastereomers, and optionally in the form of their salts and derivatives, their solvates, and / or hydrates. Any reference to steroids includes a reference to any salts or derivatives, hydrates, or solvates that may exist. Examples of possible salts and derivatives of steroids may include: alkali metal salts, such as sodium or potassium salts, sulfobenzoates, phosphates, isonicotinates, acetates, dichloroacetates, propionates, dihydrogen phosphates, palmitates, pivalates, or furoates.

[0138] As PDE4 inhibitors, compounds are preferably used that are selected from the group consisting of enprofylline, theophylline, roflumilast, Ariflo (cilomilast), tofimilast, pumafentrine, lirimilast, arofylline, atizoram, D-4418, Bay-198004, BY343, CP-325,366, D-4396 (Sch-351591), AWD-12-281 (GW-842470), NCS-613, CDP-840, D-4418, PD-168787, T-440, T-2585, V-11294A, CI-1018, CDC-801, CDC-3052, D-22888, YM-58997, Z-15370 and N-(3,5-Dichloro-1-oxo-pyridin-4-yl)-4-difluoromethoxy-3-cyclopropylmethoxybenzamide (-)p-[(4 a R*,10 bS*)-9-Ethoxy-1,2,3,4,4a,10b-hexahydro-8-methoxy-2-methylbenzo[s][1,6]naphthyridin-6-yl]-N,N-diisopropylbenzamid (R)-(+)-1-(4-Brombenzyl)-4-[(3-cyclopentyloxy)-4-methoxyphenyl]-2-pyrrolidon 3-(Cyclopentyloxy-4-methoxyphenyl)-1-(4-N'-[N-2-cyano-S-methyl-isothioureido]benzyl)-2-pyrrolidon cis[4-Cyano-4-(3-cyclopentyloxy-4-methoxyphenyl)cyclohexan-1-carbonsäure] 2-carbomethoxy-4-cyano-4-(3-cyclopropylmethoxy-4-difluoromethoxyphenyl)cyclohexan-1-on cis[4-Cyano-4-(3-cyclopropylmethoxy-4-difluormethoxyphenyl)cyclohexan-1-ol] (R)-(+)-Ethyl[4-(3-cyclopentyloxy-4-methoxyphenyl)pyrrolidin-2-yliden]acetat (S)-(-)-Ethyl[4-(3-cyclopentyloxy-4-methexyphenyl)pyrrolidin-2-yliden]acetat 9-Cyclopentyl-5,6-dihydro-7-ethyl-3-(2-thienyl)-9 H -pyrazolo[3,4-c]-1,2,4-triazolo[4,3-a]pyridin 9-Cyclopentyl-5,6-dihydro-7-ethyl-3-( tert -butyl)-9 H -pyrazolo[3,4-c]-1,2,4-triazolo[4,3-a]pyridin optionally in the form of their racemates, enantiomers, diastereomers, and optionally in the form of their pharmacologically acceptable acid addition salts, solvates, or hydrates. According to the invention, the acid addition salts of the betamimetics are preferably selected from the group consisting of hydrochloride, hydrobromide, hydroiodide, hydrosulfate, hydrophosphate, hydromethanesulfonate, hydronitrate, hydromaleate, hydroacetate, hydrocitrate, hydrofumarate, hydrotartrate, hydrooxalate, hydrosuccinate, hydrobenzoate, and hydro-p-toluenesulfonate.

[0139] As LTD4 antagonists, compounds are preferably used that are selected from the group consisting of Montelukast, Pranlukast, Zafirlukast, MCC-847 (ZD-3523), MN-001, MEN-91507 (LM-1507), VUF-5078, VUF-K-8707, L-733321 and 1-(((R)-(3-(2-(6,7-Difluor-2-quinolinyl)ethenyl)phenyl)-3-(2-(2-hydroxy-2-propyl)phenyl)thio)methylcyclopropan-essigsäure, 1-(((1(R)-3(3-(2-(2,3-Dichlorthieno[3,2-b]pyridin-5-yl)-(E)-ethenyl)phenyl)-3-(2-(1-hydroxy-1-methylethyl)phenyl)-propyl)thio)methyl)cyclopropanessigsäure [2-[[2-(4-tert-Butyl-2-thiazolyl)-5-benzofuranyl]oxymethyl]phenyl]-essigsäure optionally in the form of their racemates, enantiomers, diastereomers, and optionally in the form of their pharmacologically acceptable acid addition salts, solvates, or hydrates. According to the invention, the acid addition salts of the betamimetics are preferably selected from the group consisting of hydrochloride, hydrobromide, hydroiodide, hydrosulfate, hydrophosphate, hydromethanesulfonate, hydronitrate, hydromaleate, hydroacetate, hydrocitrate, hydrofumarate, hydrotartrate, hydrooxalate, hydrosuccinate, hydrobenzoate, and hydro-p-toluenesulfonate. Salts or derivatives that the LTD4 antagonists may be capable of forming include, for example, alkali metal salts, such as sodium or potassium salts, alkaline earth metal salts, sulfobenzoates, phosphates, isonicotinates, acetates, propionates, dihydrogen phosphates, palmitates, pivalates, or furoates.

[0140] According to the invention, the acid addition salts of the betamimetics are preferably selected from the group consisting of hydrochloride, hydrobromide, hydroiodide, hydrosulfate, hydrophosphate, hydromethanesulfonate, hydronitrate, hydromaleate, hydroacetate, hydrocitrate, hydrofumarate, hydrotartrate, hydrooxalate, hydrosuccinate, hydrobenzoate and hydro-p-toluenesulfonate.

[0141] Dopamine agonists preferably used are compounds selected from the group consisting of bromocriptine, cabergoline, alpha-dihydroergocryptine, lisuride, pergolide, pramipexole, roxindole, ropinirole, talipexole, terguride, and viozan, optionally in the form of their racemates, enantiomers, diastereomers, and optionally in the form of their pharmacologically acceptable acid addition salts, solvates, or hydrates. According to the invention, the acid addition salts of the beta-mimetics are preferably selected from the group consisting of hydrochloride, hydrobromide, hydroiodide, hydrosulfate, hydrophosphate, hydromethanesulfonate, hydronitrate, hydromaleate, hydroacetate, hydrocitrate, hydrofumarate, hydrotartrate, hydrooxalate, hydrosuccinate, hydrobenzoate, and hydro-p-toluenesulfonate.

[0142] As H1 antihistamines, compounds are preferably used which are selected from the group consisting of epinastine, cetirizine, azelastine, fexofenadine, levocabastine, loratadine, mizolastine, ketotifen, emedastine, dimetindene, clemastine, bamipine, cexchlorpheniramine, pheniramine, doxylamine, chlorphenoxamine, dimenhydrinate, diphenhydramine, promethazine, ebastine, desloratidine and meclozine, optionally in the form of their racemates, enantiomers, diastereomers and optionally in the form of their pharmacologically acceptable acid addition salts, solvates or hydrates. According to the invention, the acid addition salts of the betamimetics are preferably selected from the group consisting of hydrochloride, hydrobromide, hydroiodide, hydrosulfate, hydrophosphate, hydromethanesulfonate, hydronitrate, hydromaleate, hydroacetate, hydrocitrate, hydrofumarate, hydrotartrate, hydrooxalate, hydrosuccinate, hydrobenzoate and hydro-p-toluenesulfonate.

[0143] In addition, inhalable macromolecules can be used, as disclosed in EP 1 003 478 A1 or CA 2297174 A1.

[0144] Furthermore, the compound may originate from the group of derivatives of ergot alkaloids, triptans, CGRP inhibitors, phosphodiesterase V inhibitors, optionally in the form of their racemates, enantiomers or diastereomers, optionally in the form of their pharmacologically acceptable acid addition salts, their solvates and / or hydrates.

[0145] As derivatives of ergot alkaloids: dihydroergotamine, ergotamine. List of reference symbols 1 atomizer 31 Recess 2 Fluid 32 protective device 3 container 33 bag 4 bag 34 recording room 5 Pressure generator 35 Contact section 6 bracket 36 Outlet or nozzle assembly 7 Drive spring 37 Exhaust channel 8 Locking element 38 valve 9 conveyor pipe 39 valve element 10 check valve 40 closing spring 11 pressure chamber 41 connecting channel 12 Discharge nozzle 42 filter 13 mouthpiece 43 Passage 14 aerosol 44 piece of material 15 Supply air opening 45 Cover element 16 Upper case 46 Inlet 17 inner part 47 Distribution chamber 17a upper part of the inner part 48 Filter structure 17b lower part of the inner part 49 collection chamber 18 Housing part (lower part) 50 Outlet 19 Holding element 51 Survey 20 Spring (in the lower housing part) 52 increase 21 Container bottom 53 Support structure 22 piercing element 23 cover b Width (passage) 24 sealing h Height (passage) 25 Septum d Diameter (passage) 26 Ventilation opening l Length (passage) 27 Safety part B Width (elevation) 28 locking arm 29 locking lug

Claims

1. Atomiser (1), in the form of an inhaler for medical aerosol therapy, for atomising a fluid (2), the atomiser (1) comprising a container (3) holding the fluid (2), a discharge nozzle (12) for atomising the fluid (2), and a pressure generator (5) as a conveying means for conveying and atomising the fluid (2) having a holder (6) for the container (3), a conveyor tube (9) and a drive spring (7), the pressure generator (5) having a pressure chamber (11) for generating a spring pressure of from 5 to 60 MPa on the fluid (2), the container (3) being movable in a stroke-like manner during the fluid conveyance, pressure generation and atomisation and, during atomisation, a fluid volume of from 10 to 50 µl per stroke being released, characterised in that the atomiser (1) has protection devices (32) for preventing bacterial contamination of the fluid (2) and the protection devices (32) comprise an at least largely germ-proof filter (42) and a lockable valve (38) for blocking a channel portion for guiding the fluid, the filter and the valve (38) being arranged downstream of the pressure chamber (11), and wherein the filter (42) has such fine openings (43), that it is at least substantially germ-prove, wherein the maximum width (b), the maximum height (h) and / or the maximum diameter (d) of the openings (43) is about 0.3 nm or less.

2. Atomiser according to claim 1, characterised in that the valve (38) is arranged directly adjacent to or upstream of the discharge nozzle (12).

3. Atomiser according to claim 1, characterised in that the discharge nozzle (12) is part of a nozzle assembly (36), which has an outlet channel (37) adjoining the discharge nozzle (12), and in that the valve (38) blocks the outlet channel (37).

4. Atomiser according to any of claims 1 to 3, characterised in that the container (3) contains a plurality of doses of the fluid (2) in the delivery state.

5. Atomiser according to claim 4, characterised in that the fluid (2) is free of preservatives.

6. Atomiser according to either claim 4 or claim 5, characterised in that the container (3) is already installed in the atomiser (1) in the delivery state, but in particular is still sealed so as to be germ-proof.

7. Atomiser according to any of claims 4 to 6, characterised in that the sealed container (3) is already arranged in the atomiser (1) in the delivery state of the atomiser (1) and the atomiser (1) is designed such that the container (3) is opened within the atomiser (1) before or during the first use of the atomiser (1).

8. Atomiser according to any of claims 4 to 7, characterised in that the atomiser (1) is designed such that the container (3) is not replaceable, and in particular is not removable.

9. Atomiser according to any of the preceding claims, characterised in that the valve (38) closes automatically, preferably by spring force.

10. Atomiser according to claim 9, characterised in that the valve (38) can be opened by means of pending fluid pressure.

11. Atomiser according to any of the preceding claims, characterised in that the filter (42) has openings (43) which are produced by etching, embossing and / or laser machining.

12. Atomiser according to any of the preceding claims, characterised in that the filter (42) is made from sintered material, ceramic material, glass and / or silicon.

13. Atomiser according to any of the preceding claims, characterised in that the filter (42) forms a structural unit together with the discharge nozzle (12).

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